NCT04327661已完成3 期
Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 7
- 主要终点
- Prevention of Vomiting Measured by Vomiting Assessment (VA)
研究概览
简要总结
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of motion sickness
- •Age 18-75
排除标准
- •Nausea-inducing disorder other than motion sickness
- •History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
研究组 & 干预措施
Tradipitant High Dose
Experimental
干预措施: Tradipitant (Drug)
Tradipitant Low Dose
Experimental
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Prevention of Vomiting Measured by Vomiting Assessment (VA)
时间窗: 1 day
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
次要结局
未报告次要终点
研究者
研究点 (7)
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